Federal Register / Vol. 72, No. 183 / Friday, September 21, 2007 / Notices 54047 

IV. Issues for Discussion 

We are specifically interested in 

hearing comments regarding the 

following questions and any other 

pertinent information related to the 

feasibility of the electronic submission 

of premarket applications and other 

regulatory information related to the 

review of human drug applications 

including postmarket data sources: 

1. What would help improve the 

quality of electronic submissions to the 

agency? 

2. What would help increase the 

quantity of electronic submissions to the 

agency? 

3. How would you prioritize these 

quality and quantity improvements? 

4. What data standards are needed to 

implement these improvements? 

5. How should FDA engage 

stakeholders while developing, testing, 

and implementing these solutions? 

6. What topics are most useful to 

include in IT plans? 

7. What lead time is needed for 

stakeholders to respond to and be in 

alignment with FDA initiatives? 

8. How should FDA coordinate with 

stakeholders on the adoption and 

implementation of data standards? 

9. What data standards areas provide 

the greatest challenge? 

10. What approaches will facilitate 

the most effective and efficient adoption 

and implementation of data standards? 

11. What key areas require new or 

expanded electronic submissions 

guidance? 

12. What lessons learned and best 

practices should FDA consider as we 

transition from program-specific to 

enterprise IT solutions using a reusable 

and modular model? 

13. What specific concerns (i.e., 

security, confidentiality, etc.) exist for a 

third party entity or entities providing 

services related to electronic 

submissions and review and how can 

they be addressed? 

V. Notice of Public Meeting 

The Commissioner of Food and Drugs 

is announcing that the public meeting 

will be conducted by FDA senior 

management. Persons who wish to 

participate in the meeting must file a 

written or electronic notice of 

participation with the Division of 

Dockets Management (see ADDRESSES

and DATES). No participant may 

interrupt the presentation of another 

participant. Only the presiding officer 

and panel members may question any 

person during or at the conclusion of 

each presentation. Under 21 CFR 

10.205, representatives of the electronic 

media may be permitted, subject to 

certain limitations, to videotape, film, or 

otherwise record FDA’s public 

administrative proceedings, including 

presentations by participants. 

VI. Request for Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic notices 

of participation and comments for 

consideration. To permit time for all 

interested persons to submit data, 

information, or views on this subject, 

the administrative record of the meeting 

will remain open until 2 weeks prior to 

the public meeting. Persons who wish to 

provide additional materials for 

consideration should file these materials 

with the Division of Dockets 

Management (see ADDRESSES). You 

should annotate and organize your 

comments to identify the specific 

questions to which they refer (see 

section IV of this document). Two paper 

copies of any mailed comments are to be 

submitted, except that individuals may 

submit one paper copy. Comments are 

to be identified with the docket number 

found in brackets in the heading of this 

document. Received comments may be 

seen in Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

VII. Transcripts 

The meeting will be transcribed. 

Transcripts of the meeting will be 

available for review at the Division of 

Dockets Management (see ADDRESSES) 

and on the Internet at http:// 

www.fda.gov/ohrms/dockets 

approximately 21 days after the 

meeting. You may place orders for 

copies of the transcript through the 

Freedom of Information Office (HFI–35), 

Food and Drug Administration, 5600 

Fishers Lane, Rm. 6–30, Rockville, MD 

20857, at a cost of 10 cents per page. 

Dated: September 17, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–4692 Filed 9–18–07; 12:12 pm] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Research 

Resources; Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Center for 

Research Resources Special Emphasis Panel, 

Florida International University Site Visit. 

Date: October 18–19, 2007. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Park Plaza Hotel, 415 North Monroe 

Street, Tallahassee, FL 32301. 

Contact Person: Guo Zhang, PhD, MD, 

Scientific Review Administrator, National 

Center for Research Resources, or National 

Institutes of Health, 6701 Democracy 

Boulevard, 1 Democracy Plaza, Room 1064, 

MSC 4874, Bethesda, MD 20892–4874, 301–

435–0812, zhanggu@mail.nih.gov. 

Name of Committee: National Center for 

Research Resources Special Emphasis Panel, 

Tulane NPRC. 

Date: October 29–31, 2007. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Wyndham New Orleans, 100 Rue 

Iberville, New Orleans, LA 70130. 

Contact Person: Carol Lambert, PhD, 

Scientific Review Administrator, Office of 

Review, National Center for Research 

Resources, National Institutes of Health, 6701 

Democracy Blvd., 1 Dem. Plaza, Room 1076, 

Bethesda, MD 20892, 301–435–0814, 

lambert@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research; 93.371, Biomedical 

Technology; 93.389, Research Infrastructure, 

93.306, 93.333, National Institutes of Health, 

HHS) 

Dated: September 14, 2007. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 07–4669 Filed 9–20–07; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

mstockstill on PROD1PC66 with NOTICES

54048 Federal Register / Vol. 72, No. 183 / Friday, September 21, 2007 / Notices 

is hereby given of the following 

meetings. 

The meetings will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Initial Review Group, Digestive Diseases and 

Nutrition C Subcommittee. 

Date: October 10–11, 2007. 

Open: October 10, 2007, 8 a.m. to 8:30 a.m. 

Agenda: To review procedures and discuss 

policy. 

Place: Courtyard by Marriott Crystal City, 

2899 Jefferson Davis Highway, Arlington, VA 

22202. 

Closed: October 10, 2007, 8:30 a.m. to 4 

p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Courtyard by Marriott Crystal City, 

2899 Jefferson Davis Highway, Arlington, VA 

22202. 

Closed: October 11, 2007, 8 a.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Courtyard by Marriott Crystal City, 

2899 Jefferson Davis Highway, Arlington, VA 

22202. 

Contact Person: Dan E. Matsumoto, PhD, 

Scientific Review Administrator, Review 

Branch, DEA, NIDDK, National Institutes of 

Health, Room 749, 6707 Democracy 

Boulevard, Bethesda, MD 20892–5452, (301) 

594–8894, matsumotod@extra.niddk.nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Initial Review Group, Diabetes, 

Endocrinology and Metabolic Diseases B 

Subcommittee. 

Date: October 10–12, 2007. 

Open: October 10, 2007, 4 p.m. to 5 p.m. 

Agenda: To review procedures and discuss 

policy. 

Place: Ramada Inn Rockville, 1775 

Rockville Pike, Rockville, MD 20852. 

Closed: October 10, 2007, 5 p.m. to 8 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Ramada Inn Rockville, 1775 

Rockville Pike, Rockville, MD 20852. 

Closed: October 11, 2007, 8 a.m. to 5:30 

p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Ramada Inn Rockville, 1775 

Rockville Pike, Rockville, MD 20852. 

Closed: October 12, 2007, 8 a.m. to 12 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Ramada Inn Rockville, 1775 

Rockville Pike, Rockville, MD 20852. 

Contact Person: John F. Connaughton, PhD, 

Scientific Review Administrator, Review 

Branch, DEA, NIDDK, National Institutes of 

Health, Room 916, 6707 Democracy 

Boulevard, Bethesda, MD 20892–5452, (301) 

594–7797, 

connaughtonj@extra.niddk.nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Initial Review Group, Kidney, Urologic and 

Hematologic Diseases D Subcommittee. 

Date: October 24–25, 2007. 

Open: October 24, 2007, 8 a.m. to 8:30 a.m. 

Agenda: To review procedures and discuss 

policy. 

Place: Crystal City Courtyard by Marriott, 

2899 Jefferson Davis Hwy, Arlington, VA 

22202. 

Closed: October 24, 2007, 8:30 a.m. to 7 

p.m. 

Agenda: To review and evaluate grant 

applications 

Place: Crystal City Courtyard by Marriott, 

2899 Jefferson Davis Hwy, Arlington, VA 

22202. 

Closed: October 25, 2007, 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Crystal City Courtyard by Marriott, 

2899 Jefferson Davis Hwy, Arlington, VA 

22202. 

Contact Person: Barbara A. Woynarowska, 

PhD, Scientific Review Administrator, 

Review Branch, DEA, NIDDK, National 

Institutes of Health, Room 754, 6707 

Democracy Boulevard, Bethesda, MD 20982–

5452, (301) 402–7172, 

woynarowskab@niddk.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: September 13, 2007. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 07–4668 Filed 9–20–07; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Child Health and 

Human Development; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Child Health and Human Development Initial 

Review Group, Reproduction, Andrology, 

and Gynecology Subcommittee. 

Date: October 18, 2007. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Double Tree, 8120 Wisconsin Ave., 

Bethesda, MD 20814. 

Contact Person: Dennis Leszczynski, PhD, 

Scientific Review Administrator, Division of 

Scientific Review, National Institute of Child 

Health and Human Development, NIH, 6100 

Executive Boulevard, Room 5B01, Bethesda, 

MD 20892, (301) 435–2717, 

leszczyd@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: September 13, 2007. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 07–4670 Filed 9–20–07; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Child Health and 

Human Development; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

mstockstill on PROD1PC66 with NOTICES